Troubleshooting Microbial Excursions Best Practices - FDA and USP Regulatory Expectations & Guidance for Industry

Live, Interactive Training Webinar

Available Live On-Demand
Instructor: Barry A.Friedman Ph.D. Biography>>>

Schedule & Deliver this Live Training Webinar Privately to Your Group

Microbial Excursions are an often observed issue that occur with both non-sterile and sterile products in controlled and classified environments as well as within the microbiological laboratory. Various regulators will cite firms for these Excursions under a variety of different sections of the Code of Federal Register (CFR) to include 21 CFR 211.113(a) and (b), 211.84(d)(6), 211.165(b), and 211.192. Excursions are also cited as per United States Pharmacopeia to include USP<51>, <61>, <62>, <71>, <1072>, <1111>, and <1116>. Also, various Guidance for Industry are also included and often used within citations. One of the most notable is the September 2004 Guidance for Industry on Aseptic Processing.

Some of the most frequent excursions include those within the laboratory, the classified environment, non-conformances of personnel, and cleaning and disinfection practices. This live training webinar will review various Investigations – using various FDA Warning Letters to explore issues with bacteria and fungi. A chronology will also be included that reviews “Troubleshooting Microbial Excursions”.

The Objective of this live training webinar will be to explore the “Best Practices for Troubleshooting Microbial Excursions” and examine solutions to common microbiological problems. Please plan to bring a team to this Webinar to explore how these issues may assist you in your facilities.

Learning Benefits:
-An Overview of “Best Practices for Troubleshooting Microbial Excursions”.
-Various Code of Federal Register regulations, USP and FDA Guidance for Industry documents used by Regulators in Citations.
-Learn about the Legal Framework behind these Documents.
-Learn about Laboratory, the Classified Environment, Non-conformances of Personnel, and Cleaning and Disinfection Practices.
-Participate in an Overview of a “Troubleshooting” Exercise.
-Experience what Companies have encountered with Warning Letters.

Webinar outline and time breakdown:

10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Overview of “Best Practices”,
Overview of CFRs, USP and Guidance documents that control “Best Practices”,
Learn about the Legal Framework behind the above documents,
11:30 AM Break
11:40 AM Learn about Laboratory, the Classified Environment,
How to Use Parametric Methods,
Non-conformances of Personnel, and Cleaning and Disinfection Practices,
Participate in an Overview of a “Troubleshooting” Exercise,
Experience what Companies have encountered with Warning Letters,
12:30 PM Live Questions & Discussion

*Please note all times are Eastern Time (New York Time)

This live training webinar includes the following for each registered attendee:

  • A copy of the presentation slides
  • A certificate of training for attendee records

Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:

  • Quality Assurance personnel
  • Quality Control personnel
  • Research & Development
  • Regulatory Affairs Professionals
  • Validation
  • Auditing Professionals
  • Microbiology Professionals
  • Those that use contract manufacturing and contract testing facilities

Instructor: Barry A. Friedman Ph.D.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. Dr. Friedman is a frequent seminar speaker in the GMP areas of internal auditing, aseptic processing of sterile drug products, USP microbiology, validations and the requirements for the manufacture of Phase 1, 2 and 3 clinical trial materials. He has recently given presentations for the FDA, PDA, PTi. He is a member of AAMI, ASM, PDA and RAPS. He served as a Captain in the Medical Service Corps, U.S. Army and is the past President of the Capital Area Chapter, PDA... Full Bio>>>


Course Number: 242

System Requirements:

All Pharma Webinars live training programs audio and visual are delivered via Cisco WebEx with basic system requirements of a computer with internet access and a telephone to access the audio portion of the presentations. You can choose to access the audio through your computer.

Live Training Benefits:

• Pharma Webinars training webinars and programs are presented exclusively as live events only.

• Designed and delivered based on e-learning best practices, Pharma Webinars' live training webinars and programs are as effective as in person training.

• Live training webinars and multi-part training programs are strictly educational based, and do not promote or endorse any products or services whatsoever.

• An interactive live Q&A and discussion period is included in each live training presentation. Questions can also be submitted to the speaker via email both prior to and following the live training webinar as a means of improving participant experience, and ensuring successful topic comprehension.

• Live presentations ensure that all live training webinars and programs are engaging and informative, allowing trainees to exchange ideas through audio conferencing and live chat during each presentation in real time. Each live training session includes a dedicated live Q&A period allowing trainees to interact directly with the instructor, with quick feedback providing them with concrete understanding of the answers and the training subject itself.

• Each Pharma Webinars live training webinar and program content is updated on regular basis to provide the latest regulatory, operational and technological trends in the international pharmaceutical arena. As regulatory expectations, guidance, or industry trends change, so does our training in order to reflect those changes as soon as the changes are released.

• Pharma Webinars' instructors are the most recognized subject matter experts in the industry who are selected based on very strict qualification criteria. They are coached on the latest e-learning speaking methods in order to make each presentation engaging, memorable and very effective.

• Each registered attendee receives an exact copy of the presentation slides and other course handouts significantly reducing the learning curve as trainees can refer back to this material in the future.

• All trainees receive a Certificate of Attendance for each live training webinar and program they attend to be kept for training records.

Client Testimonials:

"The live webinar was very useful to our team, the content was relevant and the instructor was very knowledgeable" QC Microbiology Supervisor, NJ

"We were very satisfied with the live presentation; we appreciated the speaker staying on to answer all of our questions" QA Director, MA

"Our group enjoyed the live presentation and found the experience much more engaging and worthwhile than any recorded webcasts" Sr Training Manager, CA

"This was my first live training, I found it easy to connect, participate and very useful" Laboratory Analyst, PA

"We had our entire department attend this training program and found it to be very useful, I am very satisfied with the speaker's ability to keep the audience engaged" QC Manager, NY

"Given how recent the content of the webinar was, our team members were very happy with the relevance of the training" VP Clinical Operations, CA

"Is my first time to attend training, I enjoy it very much" Sr Manager, Korea

"Our department found the level of interactivity between the audience and the instructor far beyond that of any other online training that we have attended before. Well done" Director Regulatory Affairs, ON

"Our interest group was spread out over three locations and we were able to participate simultaneously and interact very easily" Lead Compliance Manager, IL

"Well satisfied with the presentation. Our team found the speaker's level of knowledge and his ability to translate that knowledge to our processes very valuable" VP Quality Operations, NC

"We were impressed with the quality of the presentation, and despite our being located in Europe we were able to participate without a hitch" QC Manager, Ireland